Radio-pharmaceuticals are typically packaged in a manner that reduces radiation exposure to the end-user of the product. Because most of these pharmaceuticals have short half-lives, radioactive content can be extremely high during manufacturing and handling of these products. Packaging containers consists of several components, with the main component being lead. Lead has a very high density and provides excellent shielding characteristics for both gamma and beta emitting radio-pharmaceuticals. Lead is also very heavy and thus contributes to ergonomically related strains during container assembly and handling.
A radio-pharmaceutical container typically consists of an outer shell, an inner shell, and a product container. The outer shell is typically formed from plastic that is bother durable and cleanable. The outer shell is durable to meet the requirements of the Department of Transportation (DOT). The outer shell must contain and protect the inner contents of the package during shipping and use of the product. The outer shell is cleanable so that any radioactive contamination can be washed off of the surface. Radioactive contamination is a possibility due to the nature of the contents and the environment where the containers are used. The outer shell typically has a label containing all of the product information such as; product name, manufacturing date, volume, specific activity, etc. The outer shell is usually and injection molded component that contains sub-parts that are assembled into a lower and upper assembly.
The inner shell, also known as the shield, fits within the outer shell. The inner shell is typically manufactured from lead with a small percentage of antimony. The inner shell is designed to provide shielding of the radioactive contents of the container. The inner shell is usually poured from molten lead into a negative void, or form. The inner shell typically includes subparts which correspond to the subparts of the outer shell.
The product container is the primary holder of the product. It can be made of plastic or glass and can be sterile or non-sterile. The product container may be kept in the shipping container during use to reduce exposure to the end-user.
The container may also include an absorbent material placed inside the inner shell to absorb fluid if the product container is breached during shipment or use. There may also be a cushioning material, such as a sponge, to protect the product container from shock during shipment or use. Additionally, there may also be an inner sleeve that can be positioned between the inner shell and the product container to segregate the product container from the lead.
Because the actual dose to be carried by the container may greatly vary from use to use, the lead shield is typically formed to be very thick so as to handle all doses it may encounter. The resulting weight of the container presents greater risks to the assemblers or handlers of the container of ergonomic or repetitive stress injuries. As lead is a non-ferrous metal, the shielding containers of the prior art do not lend themselves to handling machinery which employ magnets for transporting, and handling components.
There is therefore a need in the art for a shielded container for a radiopharmaceutical which reduces operator exposure to the radiopharmaceutical and to ergonomic and repetitive stresses relating to the manufacture, assembly, and handling of the container.